Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 2:16 AM
Study NCT ID:
NCT01739257
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Theater to Invoke Empathy and Reduce Bias in Medical Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Explicit fat bias', 'timeFrame': 'four months', 'description': 'Assessment of conscious bias against fat people (unit of measure from 11 to 99).'}, {'measure': 'implicit fat bias', 'timeFrame': 'four months', 'description': 'Measurement using the implicit association test (IAT) with scores from -2.0 to +2.0.'}, {'measure': 'empathy scale', 'timeFrame': 'four months', 'description': 'Score of Jefferson Scale of Physician Empathy (JSPE) from 20 to 180.'}], 'secondaryOutcomes': [{'measure': 'Patient-Centered Care', 'timeFrame': 'four months', 'description': 'Open-ended question on the clinical management of an asymptomatic, obese, elderly woman who is otherwise healthy, with coding for a response that is either patient-centered (ie: asking patient preferences and goals) or prescriptive (ie: telling the patient to diet and/or exercise).'}, {'measure': 'Appraisal of obesity', 'timeFrame': 'four months', 'description': 'An open-ended question asking participants whether they felt obesity was primarily an issue of discrimination (ie: civil rights) or a public health concern (ie: medical).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Medical Student Bias']}, 'descriptionModule': {'briefSummary': 'The effect of medical humanities on medical student bias and clinical management is unclear. This study characterized medical student attitudes toward obese individuals and whether reading a play employing empathic characters can modulate negative reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medical student at UC Davis, UC Irvine, or Mayo Medical School\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01739257', 'briefTitle': 'Use of Theater to Invoke Empathy and Reduce Bias in Medical Students', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'orgStudyIdInfo': {'id': '254423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theater', 'description': '1-hour dramatic reading of "The Most Massive Woman Wins"', 'interventionNames': ['Behavioral: Dramatic Reading']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lecture', 'description': '1-hour lecture on the medical management of obese patients', 'interventionNames': ['Behavioral: Medical Lecture']}], 'interventions': [{'name': 'Medical Lecture', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Lecture']}, {'name': 'Dramatic Reading', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Theater']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis School of Medicine', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Richard L Kravitz, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis School of Medicine'}, {'name': 'Rachel Hammer, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mayo Medical School'}, {'name': 'Johanna Shapiro, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UC Irvine School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Arnold P. Gold Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}